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510(k) Data Aggregation

    K Number
    K980051
    Device Name
    PALFIQUE ESTELITE PASTE
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    1998-02-24

    (49 days)

    Product Code
    EBF,DAT
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use as a tooth shade resin material in dental procedures

    Device Description

    The product is a tooth shade resin material for use in dental restorations. It may be used with Tokuyama's Mac Bond II or other brands of similar bonding agents. It is not intended for DTC use. It contains materials that are common in dental use and pose no health hazard when used according to directions.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document appears to be a 510(k) summary and an FDA clearance letter for a dental resin material, focusing on its substantial equivalence to a predicate device rather than performance metrics and validation studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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